risperidone
- Product NDC
- 58118-0077
- 11-digit product format
- 581180077
- Labeler code
- 58118
- Product ID
- 58118-0077_b0269c97-f38b-4da4-e053-2a95a90a0b52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-11-13
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-0077 | RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 6 | Legacy NDC | 20200926_a5cf7d9a-0014-44df-b6b9-d6f54f541bb7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58118-0077-8 | 58118007708 | 30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0077-8) | 2015-11-09 | 0000-00-00 | No | No | Current |